Pacira BioSciences, Inc. · NASDAQ:PCRX
Pacira BioSciences — Technical Presentation (2024)
14 slides from Pacira BioSciences's technical presentation, 2024
Slide 1: Randomized Controlled Trial: Lumbar Medial Branch Cryoneurolysis Versus Radiofrequency Ablation
Randomized Controlled Trial: Lumbar Medial Branch Cryoneurolysis Versus Radiofrequency Ablation for Chronic Low Back Pain Martin G. Ferrillo,1 O’Dane Brady,2 Kasandra Cliff,3 Mihyun Chang,2 Mary DiGiorgi2 1Albany and Saratoga Centers for Pain Management, Saratoga Springs, NY; 2Pacira BioSciences, In
Slide 2: Disclosures
DISCLOSURES Martin G. Ferrillo has received consulting fees from Boston Scientific and Pacira BioSciences, Inc. Kasandra Cliff has no relevant financial relationships or support to disclose. O’Dane Brady, Mihyun Chang, and Mary DiGiorgi are employees of Pacira BioSciences, Inc. Acknowledgements: Thi
Slide 3: Introduction
INTRODUCTION • Chronic low back pain is a common condition Liquid N2O cartridge often treated with RFA1,2 >850 psi boiling point – However, RFA can be destructive to tissue (−88° C) surrounding the targeted nerves2 • Cryoneurolysis is an alternative treatment to RFA that applies cold temperatures (b
Slide 4: Methods: Study Design
METHODS: STUDY DESIGN Study design Original follow-up Study extension period RFA + RFA + • This single-center randomized controlled Screening steroid injection‡ (n=15) steroid injection‡ (n=12) trial (NCT06016127) included participants and with facet-mediated chronic low back pain diagnostic R nerve
Slide 5: Results: Baseline Characteristics
RESULTS: BASELINE CHARACTERISTICS RFA Cryoneurolysis Total • Of 30 total participants, 15 received RFA and 15 (n=15) (n=15) (N=30) received cryoneurolysis Demographic and baseline characteristics Age, mean (SD), y 63.1 (12.7) 66.0 (17.1) 64.5 (14.9) • After the diagnostic nerve block administered Se
Slide 6: Results: Pain Outcomes
RESULTS: Adjusted LSM NRS pain scores through 360 days*,† 9 PAIN OUTCOMES 8 7 LSM NRS pain score 6 • Adjusted LSM NRS pain scores 5 4 were numerically higher with 3 RFA versus cryoneurolysis after 2 1 Day 7 of treatment 0 • Cryoneurolysis was associated with a significant decrease in RFA Cryoneuroly
Slide 7: Results: ODI Outcomes
RESULTS: Adjusted LSM ODI scores through 360 days*,† 30 ODI OUTCOMES 25 LSM ODI score 20 At Day 360, ODI scores were 15 significantly lower with 10 cryoneurolysis versus RFA 5 0 RFA Cryoneurolysis LSM ODI score P value 180 days RFA (95% CI; n=15) 18.1 (13.6, 22.6) Cryoneurolysis (95% CI; n=15) 13.3
Slide 8: ODI Outcomes (cont): Mean ODI percent change from baseline
RESULTS: ODI OUTCOMES Mean percent change in ODI from baseline* (CONT) Day 30 Day 60 Day 90 Day 120 Day 180 Day 240 Day 270 Day 300 Day 330 Day 360 Mean ODI percent change from baseline 0 The mean percent decrease in -5 ODI score from baseline was greatest at Day 360 for -10 cryoneurolysis compared
Slide 9: Results: Change in Disability Status
RESULTS: No Completely CHANGE IN Time and treatment n disability, n (%) Mild, n (%) Moderate, n (%) Severe, n (%) disabled, n (%) DISABILITY Baseline RFA 15 0 3 (20.0) 10 (66.7) 2 (13.3) 0 STATUS Cryoneurolysis 15 0 5 (33.3) 6 (40.0) 4 (26.7) 0 Day 60 15 3 (20.0) 8 (53.3) 2 (13.3) 1 (6.7) 1 (6.7) Mo
Slide 10: Results: PGIC Outcomes
RESULTS: Adjusted LSM PGIC score through 360 days* PGIC OUTCOMES 6.0 5.0 LSM PGIC score 4.0 Cryoneurolysis was associated with 3.0 significant PGIC improvements versus RFA at Day 360 2.0 1.0 0.0 Day Day Day Day Day Day Day Day Day Day Day 30 60 90 120 150 180 240 270 300 330 360 RFA Cryoneurolysis L
Slide 11: Participant Satisfaction
RESULTS: Participant satisfaction over time* PARTICIPANT SATISFACTION 100 90 Percentage of participants satisfied More participants were 80 satisfied with pain 70 management after 60 cryoneurolysis than with RFA 50 from Day 240 through Day 360 40 30 20 10 0 Day Day Day Day Day Day Day Day Day Day Da
Slide 12: Results: Safety and Additional Spinal Injection
RESULTS: SAFETY AND ADDITIONAL SPINAL INJECTION • No serious adverse events were observed over the course of the study • One mild adverse event was reported (compression fracture in the cryoneurolysis group) and was considered unrelated to study treatment by the investigator • After Day 180, 54.5% o
Slide 13: Conclusions
Participants who received cryoneurolysis without a steroid injection for low back pain had significant improvements in pain, disability, and overall impression of treatment at Day 360 compared with participants who received RFA with a concomitant steroid injection CONCLUSIONS Additionally, participa
Slide 14: Questions?
QUESTIONS?